Great Britain plans to recognise CE-marked medical devices meeting EU MDR or IVDR requirements indefinitely, but the 21 October decision still requires legislation. The government’s consultation response says the changes will be made, subject to parliamentary approval, before the earliest relevant transition period ends on 30 June 2028. Government response, next steps
For manufacturers and procurement teams, that separates the direction of policy from the rules currently governing a device’s route to market. The announcement is not a reason to discard existing transition conditions or domestic responsibilities.
What the government has decided to pursue
The response distinguishes newer EU regulations from older directive-based routes. MDR is the EU Medical Devices Regulation; IVDR is the In Vitro Diagnostic Medical Devices Regulation, covering tests that examine samples outside the body.
The government intends indefinite recognition for devices complying with those regulations. It also intends to align Great Britain’s transition for devices complying with the older Medical Devices Directive with the EU’s relevant transition timelines. The latter addresses a potential gap between Great Britain’s June 2028 deadline and the EU’s later deadline for certain legacy devices.
These are different measures. Indefinite recognition under MDR or IVDR is not an indefinite extension for every old CE certificate. Eligibility under a legacy transition remains conditional. Proposals 1 and 2 and government response
What remains the current position?
The MHRA’s existing market guidance describes time-limited CE acceptance, with deadlines in June 2028 or June 2030 depending on the device and EU legislation involved. The consultation response acknowledges those existing arrangements while setting out the intended replacement policy.
A planning document and an enacted amendment are different authorities. Until the legislation and its commencement provisions are available, the announcement alone cannot establish the exact operative rule for a particular device. Current market guidance, Introduction and next steps
| Device route | Announced direction | Important boundary |
|---|---|---|
| EU MDR or IVDR | Indefinite CE recognition | Legislative implementation is still required |
| Legacy Medical Devices Directive route | Align relevant GB transitions with EU timelines | This is conditional transition recognition, not indefinite validity of old certificates |
| Devices classified higher in GB than in the EU | No separate higher-risk reliance route under this consultation | Domestic oversight obligations continue |
The table summarises the consultation decision, not a product-specific market-access determination. Government response to proposals 1–3
Recognition does not remove domestic oversight
Manufacturers using CE recognition will still have domestic obligations. The response expressly retains MHRA registration, the UK Responsible Person requirement where applicable, and post-market surveillance. The UKCA route also remains a distinct part of the wider regulatory system.
Market access answers how a device can be supplied. Surveillance concerns what happens after supply: collecting experience, identifying problems and taking action. Those responsibilities do not disappear because a pre-market route is recognised. Our Great Britain post-market surveillance explainer covers that separate task. Executive summary and government response, Registration and representation
The policy applies to England, Scotland and Wales. Northern Ireland has a different regulatory framework; a Great Britain announcement should not be presented as rewriting that framework.
What the consultation can—and cannot—show
The response records support for reducing duplicate processes and avoiding supply disruption. It also records concerns about oversight, accountability and independent assurance of safety. The government decided against a separate reliance route for devices classified higher in Great Britain than in the EU.
Consultation responses explain the positions submitted and the government’s reasoning. They do not demonstrate that a policy has already improved supply, reduced costs or made devices safer. Those are implementation and outcome questions. Feedback and government response
The next useful evidence is the legislation itself, followed by updated MHRA instructions. Those will establish how the policy decision becomes an operational route, including the conditions that remain attached.